Lean Models of Out-tasking in Clinical Trials

With the development of new medical products becoming more complex and challenging, the pharma and biotech industry demonstrate a strong trend towards saving their R&D resources, reducing costs and increasing efficiency. A number of industry representatives strive to achieve these goals through introducing lean out-tasking models into their clinical studies.

The information presented here is based on an analysis of successful lean models which revealed a few key areas and most effective approaches to introducing lean out-tasking models. They allow to benefit from resource and geographic adaptability, use the best resources for each task, as well as reduce fixed resource consumption.

There are three major types of out-tasking models:

Fully virtual, consisting of a small core of on-staff full-time professionals and a fully integrated set of external vendors and experts.

Lean sourcing, highly relying on CROs, with sponsor’s focus being on oversight, and CROs’ focus – on delivery.

Standard sourcing, with drug development activities being shared by a sponsor and CRO.


Who Practices Lean Models and Why

Lean models are popular not only among smaller sponsors who choose not to keep a full-capacity clinical research staff. (For such companies lean out-tasking models are the most practical option.) Larger companies which use in-house staff or traditional out-tasking models are also moving towards leaner models. Pressed by the necessity to reduce their headcount, mid-size biotech and big pharma refocus their human resources into areas of higher importance and value (like clinical development), or simply because traditional models do not deliver sufficient efficiency and quality.

Along with greater efficiency of resource use when practicing lean models, both sponsors and CROs can enjoy also the advantages of faster and better problem solving, as well as improved relationships and increased commitment to them across sponsor and CRO teams.


Factors Providing for Lean Models’ Success

In-house retention of core competencies, if such staff is already in place.

The scope of valuable experiences may include such competencies as:

  • Senior-level project management, with functionally cross-trained specialists competent in such advanced aspects of project management as proactive issue recognition, risk assessment, use of metrics, etc., with the ability to perform under a lean model.
  • Quality assurance with the ability to introduce and execute an efficient and well-conceived strategy for quality oversight. When there is no such in-house specialist, this function is often outsourced to an independent specialty vendor, separate from CROs.
  • Protocol concepts which are often developed in-house by sponsors (even under lean models), or are developed on the basis of sponsor-generated outlines. Though possessing great experience in execution, CROs may lack the sufficient expertise in therapeutic areas and business strategies of their sponsors.
  • Unlike traditionally outsourced routine safety case and data management tasks, biostatistics tasks are maintained mostly in-house due to the higher level of expertise they require.


Full-service and Functional Out-tasking in Clinical Trials

Usually sponsors move into full-service lean outsoursing only after having had sufficient positive prior experience with a concrete CRO. Such experience could involve using lean models for only a section of trials, and if the results (performance or any performance-and/or-qualification based criteria) are satisfactory, sponsors begin considering a reduction of the direct oversight level.

Consequently, some sponsors find the full-service model to be sufficiently resource-efficient and to work the best for their needs – providing for them in a coordinated and seamless manner. Other sponsors opt for out-tasking only functionally to the service provider they believe to be the best in class. And even though this category of sponsors recognizes this approach as more resource-intensive, they nevertheless acknowledge that it is worth the additional effort of engaging the best available provider per each functional area. It is worth mentioning also that such sponsors as a rule have highly-qualified in-house project management professionals to successfully handle all additional tasks.


Number of CROs to Out-task to

Smaller sponsor companies transitioning from intensive oversight models or those with narrow therapeutic area, often choose to work with only one CRO. Such lean model – with maximal concentration of the business with one CRO – allows to manage efficiently the dedicated resources, the volume discounts, process integration investment, and A-team members, providing for achieving success under a lean model.

Larger sponsors – out of the fear of placing all eggs in one basket, due to a greater geographic diversity and with the aim of maintaining healthy competition in performance and pricing – choose to outsource to multiple CROs.


Out-tasking to Independent Contractors

One of the ever-present themes among lean outsourcers is the effective use of this mostly reliable and stable resource – the independent contractors. When used in mixed teams, these very role-flexible and experienced contractors can help to improve individual-level performance and raise the bar for all staff when accompanied by a performance management program.

Some of the most common factors determining the use of out-tasking in lean models are:

  • region
  • therapeutic area
  • internal resource availability
  • considerations about clinical trial phase.

However, for some companies, the use of different models for managing different types of trials proves to be efficient.


Risk-Sharing and Fixed-Price Contractual Provisions

Reducing of the probability of CRO performance dependence upon sponsor involvement at numerous touch points, risk-sharing or fixed-price contractual provisions can prove to be effective with lean oversight models. They provide CROs access to bonuses when performance targets are met, and also make them subject to penalties for failing to meet those targets.

The contractually binding Quality Agreements have also reported positive outcomes as a way to ensure the clarity of quality requirement and as a protection against it being compromised with the aim to meet budget and time targets.

Thus, this risk-sharing approach provide for CROs’ better and early engagement and fuller commitment to whatever milestone goals.


Tools and Practices to Support Lean Model Operations

When used effectively, these tools and/or practices affect results significantly when operating under a lean model:

  1. A manual describing the roles of sponsor and CRO team members such as:
  • Expectations and/or standards for staff qualifications, specific functional tasks and deliverables
  • Risk management and assessment activities
  • Escalation and communication plans, etc.

These documents should be developed in due detail, which requires considerable investment on the part of sponsors as well as CROs.

  1. Governance model – a fit-for-purpose one, with well-articulated procedures and mandates for performance and relationship management, designed for handling escalated issues and/or those with significant financial implications, and with meetings scheduled at logical frequency.
  2. A concise set of review plans for quality metrics, risk and key performance, along with associated thresholds, targets, review plans, and reports. These instruments allow also to clarify role and performance expectations, as well as to focus oversight at the adequate level.


In a Nutshell

Despite the noticeable advantages of out-tasking in clinical trials, it has also such challenges as the difficulty of finding personnel with an experience of working in lean models, and the lack of effectual control over out-tasking partners.

Nevertheless, the multinational CRO Atlant Clinical is one of those successful service providers in this market who has established efficient and seamless business processes to help our clients achieve their goals in the shortest possible period and with well-calculated expenses.